1. Field of the Invention
The present invention relates to an apparatus and methods for application of a surgical material to a target site within a body cavity. The apparatus and methods of the present invention are suitable for use in laparoscopic and endoscopic surgical procedures, as well as open-incision type procedures.
2. Background
Surgical prosthetic materials are used with a wide variety of surgical procedures. For example, prosthetic materials are often associated with hernia repair. Hernias are abnormal protrusions of an organ or other body structure through a defect or natural opening in a covering membrane, muscle or bone. Hernia repair typically involves replacement of the protruding tissue and repair or reconfiguration of the opening from which it protruded.
Surgical prostheses used in hernia repair and other procedures may include meshor gauze-like materials, which support the repaired hernia or other body structures, and/or anti-adhesion barriers, which are often placed between organs or tissues having different structures. Anti-adhesion barrier products are known to prevent the formation of adhesions between internal organs and/or the abdominal wall. Proper placement of such surgical prostheses is sometimes difficult, particularly where laparoscopic and endoscopic surgical procedures are utilized.
Laparoscopic and endoscopic surgical procedures offer significant advantages relative to conventional surgical procedures, and can often avoid the risks associated with such conventional procedures, e.g., bleeding, infection, and damage to organs, nerves and blood vessels.
In laparoscopic procedures, surgery is performed in the interior of the abdomen through narrow tubes inserted therein. Similarly, in endoscopic procedures, surgery is performed in any hollow cavity of the body through narrow endoscopic tubes inserted through small entrance wounds in the skin.
Since only small diameter incisions are required in laparoscopic and endoscopic procedures, trauma to the body (e.g., to the abdominal wall) is minimized, and the time required for healing and post-operative care is significantly shortened.
A number of devices have been developed for use in laparoscopic, endoscopic and open-incision delivery of surgical materials.
One such device is described in U.S. Pat. No. 5,503,623. The methods disclosed in this patent generally comprise grasping and furling a sheet of surgical material into a roll about a delivery tube, back-loading the delivery tube into an inserter sheath, then inserting the device into the abdomen for deploying and articulating the sheet within the abdomen. Placement of the sheet is facilitated by mechanical articulation of a grasping element.
Another device is described in U.S. Pat. No. 5,350,387. This device also is reported as being suitable for application of an adhesion prophylaxis, particularly a film-like material for use in endoscopic surgery. The apparatus disclosed includes a cylindrical application sleeve and a rod-like film carrier. An elongated reception area, e.g., a slot or clamping device, is provided at the forward end of the instrument for receiving the film. The film is frictionally engaged or grasped within the slot by roughened, opposing bearing surfaces and the adhesion prophylaxis is then wound about the film carrier for subsequent application within the body cavity. Other instruments, introduced by one or more separate trocars or cannulas, facilitate unwinding of the film.
These types of devices present certain limitations, particularly when they are used in laparoscopic and endoscopic procedures. For example, these devices are not suitable for use with most hygroscopic surgical materials; that is, those materials which absorb moisture from the air. Once hygroscopic materials become dampened (which is inevitable upon entry into a body cavity), they tend to become difficult to handle. Additionally, when folded, furled or wound about some type of inserter instrument (which is necessary in laparoscopic and endoscopic procedures), the surgical material may adhere to itself. In this case, unfolding or unwinding of the surgical material is very difficult, if not impossible. Thus, application of the particular surgical material to the target body tissue also becomes very difficult.
Another device for the endoscopic delivery of surgical elements is described in U.S. Pat. No. 5,304,187. The device described in that patent is reported as being particularly useful in the repair of herniated body tissue. Using that device, the surgical element is received through a longitudinal slot in an outer wall of a tubular member described as a housing means. Within the housing means, the element is grasped by a retainer means, then wound into a roll about the retainer means and maintained within the housing means. In preferred embodiments, the retainer means is described as a rod having two opposing convex members at its distal end. Upon entry into the body cavity, the device is positioned adjacent to the target body tissue, and the rolled surgical element is deployed, positioned and secured (e.g., with sutures, clips, staples, etc.) to the body tissue.
That device also is unsuitable for delivery of many hygroscopic surgical materials for the same reasons noted previously. Additionally, the device disclosed in that patent is particularly suited for delivery of a relatively stiff hernia repair material. Delivery of a thin, limp sheet of surgical material, e.g., a hygroscopic anti-adhesion product, would be very difficult, if not impossible, using such a device.
There remains a need for an improved apparatus for laparoscopic and endoscopic delivery of a wide variety of surgical materials to target sites within the body cavity. It would be highly desirable to develop an apparatus for laparoscopic, endoscopic, as well as open-incision delivery of such materials that could be used even for application of thin, limp, hygroscopic surgical materials. Further, it would be highly desirable to develop an apparatus for laparoscopic, endoscopic and open incision application of such materials that would not require the use of mechanical articulation in order to effectively position the surgical material at the target site, and that would not require insertion of additional instruments into the abdomen for articulation and securement of the material with respect to the target sites within the body cavity.
A central object of the present invention is to provide an apparatus suitable for use in a variety of surgical procedures, including laparoscopic, endoscopic and open incision surgical procedures, for application of a surgical material (e.g., a sheet, film, mesh or gauze) to a target site within a body cavity.
Though the apparatus of the present invention may be used for a wide variety of surgical materials, it is particularly well suited for the application of hygroscopic anti-adhesion products. Examples of such products include Seprafilm(copyright) manufactured by Genzyme Corporation and Interceed(copyright) manufactured by Johnson and Johnson.
Preferred anti-adhesion products have surfaces with very low coefficients of friction, especially when wetted, so that placement of the material between adjacent tissues will prevent adhesions from forming between the tissues and will allow some relative movement between the tissues without causing substantial tissue damage.
Such materials are typically in the form of dimensionally stable films that are easy to handle when in dry form. Further, such materials are non-adhesive, and preferred materials, such as Seprafilm(copyright), will not cling to themselves or to adjacent surfaces when in dry form. However, preferred materials also are hygroscopic; that is, they absorb moisture from the air. Once hygroscopic material becomes damp or wet, it becomes difficult to handle. More specifically, when the surface of such material becomes wetted, the film has a tendency to cling to itself, to tissue, anatomical structures and various other materials, e.g., metal and plastics.
Because of these distinctive physical properties, devices of the prior art that are presently used in laparoscopic and endoscopic procedures to apply surgical materials are not suitable for use with preferred materials, such as Seprafilm(copyright) and other materials having similar physical properties.
The apparatus of the present invention generally comprises an introducer tube and a rod-like member comprising an elongated main portion having a distal portion connected thereto, to which a support carrier and a separator layer are attached. The rod-like member loosely resembles a flagpole, with its support carrier and separator layer corresponding to the flag portion.
Using the apparatus of the present invention, the surgical material is placed between the support carrier and the separator layer and then furled about the distal portion of the rod-like member. The furled surgical material is then typically wetted and inserted into the introducer tube at its proximal end.
The apparatus is introduced into the body cavity through a trocar, cannula or an open incision and moved into proximity of the target site, e.g., a certain body tissue. The rod-like member is first extended beyond the distal end of the introducer tube into the body cavity. Typically, the furled surgical material unfurls naturally once extended beyond the end of the introducer tube. If necessary, because of the confines of the body cavity, unfurling can be carried out or completed by simple, manual rotation of the rod-like member.
The surgical material is then placed directly on the target site with the separator layer facing downward. Upon contact, the surgical material typically adheres to moistened body tissue. The rod-like member is simply pulled away from the target site using a wiping action, thereby transferring the surgical material from the applicator to the desired body tissue. The ease of transfer is due in part to the physical properties of the surgical material. For example, Seprafilm(copyright) in wet form has a greater affinity for the body tissue than for the support carrier and separator layer of the rod-like member.
The use of an irrigator may be employed to accelerate and/or enhance the transfer of the surgical material to the target site. For example, once the surgical material has been placed on the target site, the corners of the support carrier may be dabbed with irrigation fluids using an irrigator.
In a particularly preferred embodiment of the present invention, the proximal end of the introducer tube comprises an open, slotted area on a portion of the outer wall thereof. This open area may be used to support the distal portion of the rod-like member during furling to produce an even, tightly furled surgical material located between the support carrier and separator layer. The furled surgical material can then easily be inserted into the introducer tube for subsequent application within the body cavity.
In another embodiment of the present invention, the proximal end of the introducer tube is flared to facilitate insertion of the rod-like member with its furled surgical material into the introducer tube.
In preferred embodiments of the present invention, the length of the rod-like member exceeds that of the introducer tube. This feature allows the surgeon to control the rod-like member from a position external to the body cavity, and permits extension of the rod-like member beyond the distal end of the introducer tube for delivery of the surgical material to the target site.
The diameter of the rod-like member is tailored to permit facile insertion and movement with respect to the introducer tube. In preferred embodiments of the present invention, the rod-like member has a reduced diameter at its distal end to accommodate the surgical material furled thereabout.
Preferably, the support carrier and separator layer comprise a woven screen media or mesh, e.g., media or mesh products available in a wide variety of weave configurations from Tetko, Inc., Sefar America, Inc. and Saati Tech. More preferably, the mesh comprises at least one of a nylon or polyolefin, e.g., polypropylene, polyester or teflon material. Most preferably, the mesh comprises a polyester material.
In particularly preferred embodiments of the present invention the support carrier is imprinted, e.g., with text, color or other design. Such an imprint aids in the visualization and placement of the surgical material during the application procedure.
The separator layer is preferably Y-shaped and its dimensions are tailored according to those of the support carrier.
In preferred embodiments of the present invention, the rod-like member further comprises an elongated handle adapted to control the movement of the rod-like member within the body cavity from a position external to the body cavity.
In an alternate preferred embodiment of the present invention, the rod-like member is configured for axial flexibility, e.g., it can bend in any axial direction. In this particular embodiment, the rod-like member comprises an outer tube surrounding an inner member having a distal portion to which the support carrier and separator layer are attached, the distal portion of the inner member being connected to the main portion by a flexible connector, and a device adapted to reversibly alter the flexibility of such distal portion. This design feature permits movement of the rod-like member in more than a single plane.
Preferably, the device for altering the flexibility of the rod-like member is easily accessible from a position external to the body cavity. In that way, the flexibility of the leading or distal end of the rod-like member can be adjusted without removing the apparatus from the body cavity.
In preferred embodiments of the present invention, the device comprises a control unit, e.g., a push-button assembly, located on the handle portion of the rod-like member. When the push-button is not depressed, the rod-like member operates in its semi-rigid form. Depressing the push-button of the control unit causes the actuation, e.g., extension, of the inner member such that at least a portion of the flexible connector is advanced beyond the distal end of the outer tube of the rod-like member rendering the leading end of the rod-like member highly flexible. The inner member and flexible connector may be retracted and extended as needed to reversibly alter the flexibility of the rod-like member.
Another object of this invention is to provide methods for using the apparatus of the present invention.
One preferred method of the present invention for delivering a surgical material to a target site within a body cavity comprises providing an apparatus in accordance with the present invention; placing the surgical material between the support carrier and separator layer of the rod-like member and furling thereabout; inserting the rod-like member into the proximal end of the introducer tube and inserting the apparatus into the body cavity, e.g., with the use of a trocar or cannula, or via an open incision; positioning the apparatus within proximity of the target site; extending the rod-like member beyond the distal end of the introducer tube and allowing the surgical material at least partially to unfurl; applying the surgical material to the target site; and withdrawing the apparatus from the body cavity.
The preferred methods of the present invention may also comprise wetting the furled surgical material with suitable irrigation fluids prior to inserting it into the introducer tube.
The preferred methods of the present invention may also comprise altering the flexibility of the leading or distal end of the rod-like member to facilitate positioning of the rod-like member in proximity to the target site.
The preferred methods of the present invention may also comprise providing a visual indicator, e.g., in the form of text, color or other design, on the support carrier of the rod-like member to assist in the placement and application of the surgical material.
The preferred methods of the present invention may further comprise irrigating the surgical material following placement on the target site to accelerate and/or enhance transfer of the surgical material from the support carrier and separator layer to the target site.
The foregoing and other objects, features and advantages of the invention will become better understood with reference to the following description and appended claims.